Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

A new approach to HIV prevention currently being studied includes the use of topical microbicides, substances that kill microbes. The purpose of this study is to determine the levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are expecting to deliver by cesarean.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Microbicide Trials Network
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• General good health

• HIV uninfected

• Hepatitis B surface antigen negative at screening and enrollment

• Viable, single pregnancy delivered by cesarean section planned between 37 0/7 to 41 6/7 weeks of pregnancy

• Normal Pap smear in the 12 months prior to study entry

• Willing to abstain from vaginal, anal, and receptive oral sex for at least 2 weeks after gel administration

• Willing to abstain from intravaginal products and practices (including douching) during study participation

Exclusion Criteria:

• Maternal or fetal condition that requires urgent cesarean section

• Documented rupture of the amniotic membranes

• Known disease in the mother that has a predictable negative effect on placental function

• Known placental/fetal abnormalities that could affect placental transfer. More information on this criterion can be found in the protocol.

• Previously demonstrated hypersensitivity to any components of tenofovir 1% gel

• Certain abnormal laboratory values

• Use of vaginal medications within 48 hours of study entry

• Untreated sexually transmitted infection (STI) or exposure to partner's STI, including chlamydia, gonorrhea, trichomoniasis, and nongonococcal urethritis

• Symptomatic vaginitis, including bacterial vaginosis and vulvovaginal candidiasis. Participants with asymptomatic signs of bacterial vaginosis and/or yeast not excluded.

• Participation in any other investigational drug or device trial within 30 days of study entry

• Any social or medical condition that, in the opinion of the investigator, would interfere with the study